Higher rates of mucosal healing for ulcerative colitis and Crohn’s Disease patients

Takeda-Crohns-diseaseTakeda Pharmaceutical Company Limited announced new real-world data evaluating the comparative effectiveness of Entyvio (vedolizumab) and tumor necrosis factor-alpha (TNFα)-antagonist therapy in patients with moderately to severely active ulcerative colitis or Crohn's disease.

These data were presented as oral presentations at the 13th Congress of the European Crohn's and Colitis Organization (ECCO) from 14 to 17 February 2018 in Vienna, Austria. These analyses observed that patients with UC treated with Entyvio compared to TNFα-antagonist therapy had statistically significant higher 12-month cumulative rates of mucosal healing (50 percent vs 42 percent, hazard ratio [HR] 1.73, 95 percent confidence interval [CI] 1.10-2.73) and clinical remission (54 percent vs 37 percent; HR 1.54, 95 percent CI 1.08-2.18), and numerically higher steroid-free clinical remission rates (49 percent vs 38 percent; HR 1.43, 95 percent CI 0.79-2.60). In CD, results reported statistically significant higher 12-month cumulative rates of mucosal healing (50 percent vs 41 percent; HR 1.67, 95 percent CI 1.13-2.47), and numerically higher rates of clinical remission (38 percent vs 34 percent; HR 1.27, 95 percent CI 0.91-1.78) and steroid-free clinical remission (26 percent vs 18 percent; HR 1.75, 95 percent CI 0.90-3.43) compared to TNFα-antagonist therapy. These analyses were conducted by the Victory (Vedolizumab Health OuTComes in InflammatORY Bowel Diseases) Consortium.

‘These data from the VICTORY Consortium highlight the effectiveness of Entyvio in achieving mucosal healing and clinical remission in the real-world, and support the use of Entyvio as a first-line biologic therapy,’ says Professor William Sandborn, M.D., chief, Division of Gastroenterology, University of California San Diego. ‘While additional research is needed to confirm these findings, these are important comparative effectiveness analyses of real-world data involving Entyvio and TNFα-antagonist therapy, which further aid our understanding of biologic therapy in clinical practice.’

Of the 646 UC and 1,122 CD Victory Consortium patients, data from 334 UC (n=167 Entyvio patients; 49 percent male; median age 36 years) and 538 CD (n=269 Entyvio patients; 44 percent male; median age 35 years) were analysed. Entyvio patients were matched (1:1) to patients on anti-TNFα therapy using propensity scores to control for baseline differences between groups. Researchers used Cox proportional hazard models to compare cumulative rates of mucosal healing (absence of ulcers or erosions for CD; Mayo endoscopic sub-score of 0 or 1 for UC), clinical remission (complete resolution of symptoms based on Physician Global Assessment) and steroid-free clinical remission (on steroids at baseline, tapered off, no repeat steroid prescription for four weeks). Findings were reported after adjusting for concomitant steroid or immunomodulator use, disease location (CD study only; isolated small bowel, ileocolonic, isolated colonic), and number of prior TNFα-antagonists used.

New clinical data also being presented at ECCO from the Phase 3b open-label prospective multicenter study (VERSIFY) evaluating the efficacy of Entyvio on complete mucosal healing (absence of ulcerations), endoscopic remission (Simple endoscopic score for CD [SES-CD] ≤4) and endoscopic response (50 percent decrease in SES-CD from baseline) provide insight into complete mucosal healing in CD. Results at week 26 found Entyvio induced complete mucosal healing (15 percent), endoscopic remission (12 percent) and endoscopic response (25 percent) in the overall population of CD patients, particularly in an anti-TNFα-naïve setting (complete mucosal healing 24 percent, endoscopic remission 20 percent, and endoscopic response 28 percent). The trial included 101 patients with moderately to severely active CD who had previously experienced treatment failure with corticosteroids, immunomodulators, and/or at least one TNFα-antagonist therapy. In this study, 46 percent of patients were categorised as having severe endoscopic activity at entry (SES-CD score of >15). Patients received Entyvio 300 mg intravenously at weeks 0, 2, 6, and then every eight weeks for 26 weeks, followed by a 26-week extension period. Dose escalation was not permitted.

‘Endoscopic remission and mucosal healing are important targets in the management of Crohn's disease and ulcerative colitis, as they look beyond symptoms to show how disease activity could be impacting underlying bowel damage. The Versify clinical study generated positive results in complete mucosal healing and endoscopic remission rates in Crohn's disease, particularly in anti-TNFα-naïve patients. Looking across the Entyvio data presented at ECCO, we're encouraged by the large compendium of data for Entyvio regarding endoscopic remission and mucosal healing in both clinical studies and the real-world setting,’ says Mona Khalid, senior director, head of Evidence and Value Generation, Takeda Pharmaceuticals.

At this year's ECCO congress, Takeda sponsored 33 posters and presentations on Entyvio, including real-world analyses and clinical studies evaluating the impact of Entyvio on long-term remission, comparative efficacy/effectiveness, mucosal healing, resource utilisation, and in special patient populations across CD and UC.

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